CurrentUnitedHealthcarePolicy CS123IN.11

Transcatheter Procedures for Heart Valve Conditions (for Indiana Only)

State-specific UnitedHealthcare medical policy (Indiana) defining medical necessity and not medically necessary positions for transcatheter procedures for aortic, mitral, pulmonary, and tricuspid valves, listing applicable CPT codes and documentation requirements; includes evidence summaries for multiple device types and procedures. This is Part 1 of 3.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Indiana Only)

Policy CodePolicy CS123IN.11

Change TypeMaterial and non-material updates (added T-TEER coverage criteria; revised tricuspid replacement stance)

Effective DateJanuary 1, 2026

Next Review DateN/A

Key ActionProviders must maintain legible medical records documenting history, physical exam, and pertinent diagnostic test results to support medical necessity and make them available upon request.

POLICY UPDATE CHANGES

Added language indicating transcatheter edge-to-edge repair of the tricuspid heart valve is proven and medically necessary when used according to FDA labeled indications and the individual meets specified criteria.

Replaced language that previously labeled 'transcatheter tricuspid heart valve repair, reconstruction, or replacement' as unproven and not medically necessary with a narrower statement: 'transcatheter tricuspid heart valve reconstruction or replacement is unproven and not medically necessary.'

Added Medical Records Documentation Used for Reviews language emphasizing federal/state/contractual requirements and that documentation may be required to assess criteria but does not guarantee coverage.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect most current information.

Archived previous policy version CS123IN.10

Coverage Summary

This Indiana-specific policy (effective 2026-01-01; Part 1 of 3) addresses transcatheter (catheter-based) procedures for the four heart valves: aortic, mitral, pulmonary, and tricuspid. Coverage stance is mixed: some procedures are listed as proven/medically necessary when criteria are met (e.g., TAVR per Indiana reference, mitral TEER per InterQual, transcatheter pulmonary valve replacement, and now transcatheter tricuspid edge-to-edge repair), while other transcatheter procedures remain unproven/not medically necessary (notably transcatheter mitral reconstruction or replacement, most annuloplasty outside InterQual TEER, valve-in-valve and caval valve implantation (CAVI), and cerebral embolic protection in this policy). The revision adds a new covered indication: transcatheter tricuspid edge-to-edge repair (T-TEER) as medically necessary when FDA-labeled and specific clinical criteria are met, and clarifies that transcatheter tricuspid reconstruction or replacement remains unproven/not medically necessary. Applicable CPT and HCPCS procedure codes are listed for reference.

Key thresholds & quick facts

Pulmonary stenosis thresholdmean RVOT gradient ≥ 35 mmHg

GDMT (stable) prior to tricuspid TEER≥ 30 days

Pulmonary artery systolic pressure limit for tricuspid TEER< 70 mmHg

NYHA functional class requirement for tricuspid TEERClass II or greater

Surgical risk requirementIntermediate or greater risk as determined by local heart team

State scopeIndiana only

Policy effective dateJanuary 1, 2026

Medical-Necessity Criteria (by valve/procedure)

General Application

Policy applies only to the state of Indiana

Aortic Valve (TAVR/TAVI)

Refer to Indiana Health Coverage Programs Provider Reference Module: Surgical Services for TAVR and to InterQual for mitral TEER criteria.

Transcatheter aortic valve replacement (TAVR/TAVI) coverage governed by Indiana Health Coverage Programs, Provider Reference Module: Surgical Services

Refer to state provider reference module for specific coverage rules

Mitral Valve - Transcatheter Edge-to-Edge Repair (TEER)

TEER is covered when InterQual CP: Procedures, Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) criteria are met.

Coding

Applicable CPT / Procedure Codes (listed for reference)CPT

0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus
0483T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed
0484T	Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (e.g., thoracotomy, transapical)
0543T	Transapical mitral valve repair, including transthoracic echocardiography, with placement of artificial chordae tendineae
0544T	Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture
0545T	Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approach
0569T	Transcatheter tricuspid valve repair, percutaneous approach; initial prosthesis
0570T	Transcatheter tricuspid valve repair, percutaneous approach; each additional prosthesis during same session
0646T	Transcatheter tricuspid valve implantation (TTVI)/replacement with prosthetic valve, percutaneous approach
0805T	Transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI); percutaneous femoral vein approach

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Codes Not Managed for Medical Necessity Review (Indiana at policy effective date)CPT

0345T	See note: codes labeled with an asterisk (*) are not managed for medical necessity review for Indiana at policy effective date
0483T
0484T
0543T
0544T
0545T
0569T
0570T
0646T
0805T

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FDA product/Device references (informational)mixed

Product Code NPT	Transcatheter aortic valve prostheses (PMA database)
Product Code NPU	Transcatheter mitral valve prostheses (PMA database)
Product Code NKM	Transcatheter mitral valve repair devices (PMA database)
Product Code NPV	Transcatheter pulmonary valve prostheses (PMA database)
Product Code NPW	Transcatheter tricuspid valve prostheses (PMA database)
Product Code NPS	Transcatheter tricuspid valve repair devices (PMA database)
Product Code PUM	Cerebral embolic protection devices (De Novo/510(k) database)

Named FDA-approved devices (informational list)mixed

Evolut FX/PRO/R	Medtronic transcatheter aortic valves (PMA entries referenced)
Navitor	Abbott transcatheter aortic valve
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA	Edwards Lifesciences transcatheter aortic valves
MitraClip	Abbott transcatheter mitral valve repair device
PASCAL	Edwards Lifesciences transcatheter mitral repair device
Harmony	Medtronic transcatheter pulmonary valve
Melody	Medtronic transcatheter pulmonary valve
SAPIEN 3 (pulmonary) / SAPIEN 3 with Alterra Adaptive Prestent	Edwards Lifesciences pulmonary devices
EVOQUE	Edwards Lifesciences transcatheter tricuspid valve prosthesis
TriClip	Abbott transcatheter tricuspid valve repair device

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Other products without full FDA approval (informational)mixedExperimental

Cardioband	Device; may not have full FDA approval
Carillon Mitral Contour System	Device; may not have full FDA approval
Harpoon	Device; may not have full FDA approval
Intrepid	Medtronic; may not have full FDA approval
NeoChord	Device; may not have full FDA approval
Tiara	Neovasc; may not have full FDA approval
TricValve	Device; may not have full FDA approval
TriGUARD 3	Keystone Heart; may not have full FDA approval

Provider Actions and Documentation Requirements

Documentation Required

Medical record documentation required

Providers must maintain legible medical records documenting history, physical exam, and pertinent diagnostic test results to support medical necessity; records must be made available upon request.

Prior Authorization

Prior authorization note for Indiana

Prior authorization note for Indiana: affected CPT codes — 0345T, 0483T, 0484T, 0543T, 0544T, 0545T, 0569T, 0570T, 0646T, 0805T, 0806T, 33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369, 33370, 33418, 33419, 33477, 93799. Codes labeled with an asterisk are not managed for medical necessity review for Indiana at the policy effective date; refer to the most up-to-date PA/Notification list for Indiana.

Affected codes: 0345T, 0483T, 0484T, 0543T, 0544T, 0545T, 0569T, 0570T, 0646T, 0805T, 0806T, 33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369, 33370, 33418, 33419, 33477, 93799

Background and Evidence Summary

Background: transcatheter heart valve procedures are described as minimally invasive alternatives to surgical repair or replacement, using catheter-delivered devices (stent-like scaffolds with bioprosthetic valves or leaflet repair clips) to treat valvular stenosis or regurgitation without open-heart surgery or cardiopulmonary bypass. Device types include transcatheter valve prostheses (aortic, mitral, pulmonary, tricuspid), leaflet repair devices (edge-to-edge clips), annuloplasty and annulus reconstruction devices, artificial chordae systems, and emerging approaches (CAVI, ViV). Access routes depend on valve and device but commonly include transfemoral (arterial or venous), transseptal, transapical, transthoracic, and other surgical exposures. Coverage determinations are based on FDA labeling, evidence from RCTs, registries, and systematic reviews, and professional guidance; literature and registry evidence summaries for TMVR, percutaneous annuloplasty, pulmonary valve implantation, and tricuspid interventions are included in the policy to explain the rationale for proven versus unproven decisions.

Study / Source	Key data	Notes/limitations
TMVR CHOICE-MI (Ludwig et al. 2023a)
n=400; technical success 95.2%; MR ≤1+ at discharge in 95.2%; 30-day mortality 9.2%; 1-year mortality 27.9%; 2-year mortality 38.1%.
Non-comparative registry; high attrition and limited long-term comparative data.
TMVR vs TEER (Ludwig et al. 2023b)
TMVR n=235 vs TEER n=411 (propensity-matched); 30-day mortality 6.8% vs 3.8%; 1-year mortality 25.8% vs 18.9%; no significant mortality difference beyond 30 days.
Observational with propensity matching; residual confounding possible.
Carillon REDUCE FMR (Witte et al. 2019)
Randomized, sham-controlled RCT n=120 (treatment n=87, sham n=33); primary endpoint met: reduction in mitral regurgitant volume at 12 months; 84% implantation rate in treatment arm.
Proof-of-concept RCT not powered for clinical endpoints; high attrition in some studies and limited long-term data.
Alterra pivotal trial (Dimas et al. 2024)
60 implanted (of 97 screened); no valve dysfunction at 6 months; at 2 years 92.5% had mild or less PR; no deaths or explants through 2 years.
Single-arm pivotal study; limited sample size and need for longer-term durability data.
COMPASSION S3 (Lim et al. 2023)
n=58; device success 98% at discharge; 1-year valve dysfunction composite 4.3%; no mortality, endocarditis, thrombosis, or stent fractures at 1 year.
Single-arm study with limited long-term follow-up; generalizability and durability uncertainties.
TPV outcomes (Melody/Harmony registries/trials)
Freedom from valve dysfunction or reintervention ~93.5% at 1 year; freedom from stent fracture 77.8% at 14 months; 10-year freedom from TPV dysfunction 53% (Jones et al. 2022).
Registry and cohort data with variable follow-up; pediatric/young adult populations; durability issues over long term.
TTVR TRISCEND II (EVOQUE) phase 2/phase 3 (Hahn et al. 2024 / TRISCEND II)
Phase 2/3 randomized trial full cohort n=400 (2:1 TTVR n=267 vs control n=133): 1-year mortality 12.6% vs 15.2%; HF hospitalization 20.9% vs 26.1%; KCCQ-OS ≥10 pts in 66.4% vs 36.5%; TR ≤ mild 95.3% vs 16.1%.
Open-label RCT with early safety signals (higher severe bleeding and pacemaker rates); follow-up relatively short and concerns about early adverse events.
TRISCEND safety signals (from trial reports)
Severe bleeding 15.4% (TTVR) vs 5.3% (control); new permanent pacemaker 17.4% vs 2.3%.
Safety concerns including bleeding and pacemaker need; open-label design limits some assessments.
T-TEER TRILUMINATE (TRILUMINATE RCT and single-arm data)
TRILUMINATE pivotal RCT n=350 (175 TriClip vs 175 medical): reduced TR severity (TR ≤2+ at 30 days 87% vs 4.8%); 2-year randomized data (n=572 in expanded RCT) showed reduced HF hospitalizations and sustained TR and QoL improvements; procedural success ~97% in meta-analyses.
Some endpoints (quality of life) possibly influenced by lack of participant masking; longer-term mortality benefit not established; crossover in trials affects some comparisons.
Sentinel cerebral protection RCT (Kapadia et al. 2022)
Large RCT n=3000: stroke within 72 hours 2.3% (CEP) vs 2.9% (control); disabling stroke 0.5% vs 1.3%; device deployment success ~94.4%.
No significant reduction in primary stroke endpoint; applies to Sentinel device only; short-term follow-up and applicability to other devices uncertain.

Important thresholds & selection criteria (quick reference)

Pulmonary mean RVOT gradient≥ 35 mmHg

Stable guideline-directed medical therapy (GDMT)≥ 30 days

Pulmonary artery systolic pressure< 70 mmHg

Not Medically Necessary / Experimental Procedures

Not Medically Necessary Determinations (Consolidated)

Consolidated not medically necessary determinations from mitral other procedures, tricuspid other procedures, and other devices/procedures.

Mitral - any of the following: Transcatheter mitral heart valve repair (e.g., annuloplasty) except as addressed in InterQual criteria is unproven and not medically necessary

Tricuspid - any of the following: Transcatheter tricuspid heart valve reconstruction or replacement is unproven and not medically necessary

Other devices - any of the following: Cerebral protection devices (e.g., Sentinel™), Valve-in-valve (ViV) for mitral/pulmonary/tricuspid, and CAVI are unproven and not medically necessary

Specific items listed in policy

Explanatory note on evidence insufficiency: The policy concludes that evidence is insufficient to support many newer or more invasive transcatheter procedures — for example, transcatheter mitral valve replacement and most mitral annuloplasty approaches lack high-quality long-term comparative data and are considered unproven/not medically necessary. Similarly, while transcatheter tricuspid replacement (TTVR) has promising trial and registry results, reconstruction/replacement approaches for the tricuspid valve remain unproven and not medically necessary per the recent policy revision; T-TEER was moved to proven/medically necessary only when the patient meets specified FDA‑labeled and clinical criteria. The policy bases these positions on RCTs, registries, systematic reviews, and expert guidance summarized in the policy.

Revision History

2026-01-01material_change_addedLatest

Added coverage criteria making transcatheter edge-to-edge repair (T-TEER) of the tricuspid valve proven and medically necessary when used per FDA labeling and the patient meets all specified criteria: symptomatic severe TR; stable (≥ 30 days) guideline-directed medical therapy (GDMT); symptomatic NYHA class II or greater; pulmonary artery systolic pressure < 70 mmHg; and intermediate or greater surgical risk as determined by a local heart team including board-certified specialists.

2026-01-01material_change_revisedLatest

Revised policy language to narrow the prior unproven stance: replaced the broader statement that 'transcatheter tricuspid heart valve repair, reconstruction, or replacement is unproven and not medically necessary' with a narrower statement that 'transcatheter tricuspid heart valve reconstruction or replacement is unproven and not medically necessary' (i.e., excluding FDA-labeled T-TEER from the unproven category when criteria met).

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (for Indiana Only)

Policy CodePolicy CS123IN.11

Change TypeMaterial and non-material updates (added T-TEER coverage criteria; revised tricuspid replacement stance)

Effective DateJanuary 1, 2026

Next Review DateN/A

Key ActionProviders must maintain legible medical records documenting history, physical exam, and pertinent diagnostic test results to support medical necessity and make them available upon request.

On This Page

Mitral Valve - Other Transcatheter Mitral Procedures

Other transcatheter mitral procedures (outside InterQual TEER) are considered unproven/not medically necessary.

Any of the following: Transcatheter mitral heart valve repair (e.g., annuloplasty) except as addressed in InterQual criteria is unproven and not medically necessary due to insufficient evidence of efficacy

Transcatheter mitral heart valve reconstruction or replacement is unproven and not medically necessary due to insufficient evidence of efficacy

Includes TMVR; insufficient quality evidence

Pulmonary Valve - Transcatheter Pulmonary Valve Replacement

Transcatheter pulmonary valve replacement is proven/medically necessary when used per FDA labeling and for the listed clinical indications.

Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions

Device-specific FDA labeling must be followed

One of the following clinical indications: Moderate or greater pulmonary regurgitation

Pulmonary stenosis with a mean RVOT gradient ≥ 35 mmHg≥ 35 mmHg

Mean RVOT gradient threshold per policy

Tricuspid Valve - Transcatheter Edge-to-Edge Repair

T-TEER is proven/medically necessary when ALL criteria below are met and device is used per FDA labeling.

ALL criteria: Symptomatic Severe Tricuspid Regurgitation (TR)

Definition of Symptomatic Severe TR in policy definitions

Receiving stable (≥ 30 days) guideline-directed medical therapy (GDMT) for heart failure≥ 30 days

Stable GDMT duration required

Symptomatic New York Heart Association (NYHA) class II or greaterNYHA class II+

NYHA definitions in policy

Pulmonary artery systolic pressure of < 70 mmHg< 70 mmHg

PA systolic pressure limit for eligibility

Intermediate or greater risk for surgery as determined by the local heart team (cardiac surgery, interventional cardiology, echocardiology, heart failure specialists)

Local heart team must determine surgical risk

Tricuspid Valve - Other Transcatheter Tricuspid Procedures

Other transcatheter tricuspid reconstruction or replacement remain unproven and not medically necessary.

Transcatheter tricuspid heart valve reconstruction or replacement is unproven and not medically necessary due to insufficient evidence of efficacy

Policy retained revised language removing 'repair' from unproven category

Other Devices and Procedures (Unproven / Not Medically Necessary)

The policy lists several devices/procedures considered unproven and not medically necessary.

Any of the following: Cerebral protection devices (e.g., Sentinel™) are unproven and not medically necessary due to insufficient evidence of efficacy

Policy cites RCT with no definitive stroke benefit

Valve-in-valve (ViV) replacement within a failed bioprosthesis for mitral, pulmonary, or tricuspid valves is unproven and not medically necessary due to insufficient evidence of efficacy

Policy states evidence evolving and insufficient quality

Transcatheter superior and inferior vena cava prosthetic valve implantation (CAVI) is unproven and not medically necessary due to insufficient evidence of efficacy

Evidence limited by small studies and short follow-up

Medical Records Documentation

Documentation expectations used to support medical necessity during reviews.

Patient medical record must contain documentation supporting medical necessity including relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures

Documentation must be legible and available upon request

Documentation must be legible, maintained in the patient's medical record, and made available upon request

Documentation of criteria does not guarantee coverage

Benefit coverage determined by federal, state, contractual requirements and applicable laws; documentation of criteria does not guarantee coverage

Transcatheter tricuspid edge-to-edge repair — coverage criteria (added 01/01/2026)

New coverage rule effective 01/01/2026: T-TEER covered when ALL listed criteria met (and device used per FDA labeling).

ALL criteria: Procedure is transcatheter edge-to-edge repair of the tricuspid heart valve performed according to FDA labeled indications, contraindications, warnings, and precautions

Coverage requires adherence to FDA labeling

Symptomatic Severe Tricuspid Regurgitation (TR)

See policy definitions for Stage D TR criteria

Receiving stable (≥ 30 days) guideline-directed medical therapy (GDMT) for heart failure≥ 30 days

Stable GDMT duration required

Symptomatic New York Heart Association (NYHA) class II or greaterNYHA class II+

NYHA definitions in policy

Pulmonary artery systolic pressure of < 70 mmHg< 70 mmHg

PA systolic pressure threshold required for coverage

Intermediate or greater risk for surgery as determined by the local heart team which includes board-certified specialists in cardiac surgery, interventional cardiology, echocardiology, and heart failure

Heart team must document surgical risk determination

Transcatheter tricuspid reconstruction or replacement — coverage stance

Revised policy language clarifies that tricuspid reconstruction or replacement remain unproven/not medically necessary; 'repair' moved to proven when criteria met.

Transcatheter tricuspid heart valve reconstruction or replacement is considered unproven and not medically necessary due to insufficient evidence of efficacy

Policy language revised to narrow unproven stance

Documentation Required

Patient selection and anatomy documentation

Document that the patient meets anatomical and symptomatic trial/guideline criteria; include TR/MR severity, NYHA class, left ventricular ejection fraction, left ventricular dimensions, and prior therapies to justify transcatheter intervention.

TR/MR severity (per definitions/guidelines)
NYHA functional class
Left ventricular ejection fraction (LVEF) and LV dimensions
Prior therapies and response (including duration of GDMT)

Documentation Required

Center and operator requirements

Procedures should be performed at Comprehensive Valve Centers with recommended operator and institutional qualifications per ACC/STS/SCAI/AATS expert consensus; document center/operator qualifications accordingly.

Perform procedures at Comprehensive Valve Centers per ACC/STS/SCAI/AATS consensus
Ensure operator and institutional qualifications meet expert guidance

Documentation Required

Evidence limitations to document

When using newer procedures (TTVR, CAVI, CEP), document that the patient was considered high or prohibitive surgical risk and that uncertainties and limited long-term data were reviewed with the patient.

Document high or prohibitive surgical risk justification
Document discussion of limited long-term evidence and uncertainties

Prior Authorization

Coverage requires meeting clinical criteria and FDA labeling

Coverage requires that the device/procedure be performed consistent with FDA labeled indications, contraindications, warnings, and precautions; documentation in the medical record may be required to assess whether the member meets clinical criteria.

Device/procedure must be consistent with FDA labeled indications and warnings
Medical records may be requested to verify clinical criteria

Documentation Required

Heart team determination required for surgical risk

Local heart team must determine intermediate or greater surgical risk; the heart team should include board-certified specialists in cardiac surgery, interventional cardiology, echocardiology, and heart failure — document team composition and determination.

Heart team must include cardiac surgery, interventional cardiology, echocardiology, and heart failure specialists
Document the heart team's determination of surgical risk (intermediate or greater)

- NYHA: New York Heart Association functional classification I–IV describing limitation of physical activity in heart failure. - PROM: Predicted Risk of Mortality — STS PROM score predicting 30‑day mortality after cardiac procedures. - SDM: Shared Decision-Making — process by which physician and patient select treatment reflecting evidence and patient preferences. - Symptomatic Severe TR: Stage D tricuspid regurgitation with valve hemodynamics (e.g., central jet in RA ≥ 50%, vena contracta ≥ 0.7 cm, ERO ≥ 0.40 cm2, regurgitant volume ≥ 45 mL, hepatic vein systolic flow reversal), RA/RV dilation and symptoms. - T-TEER: Transcatheter tricuspid edge-to-edge repair (e.g., TriClip). - TTVR: Transcatheter tricuspid valve replacement (e.g., EVOQUE). - CAVI: Caval Valve Implantation — placement of valve(s) in the vena cavae to treat TR symptoms. - ViV: Valve‑in‑Valve — transcatheter valve implanted within a degenerated surgical bioprosthesis. - CEP: Cerebral embolic protection device (e.g., Sentinel) used during TAVR.

Other products without full FDA approval (informational)mixedExperimental

Cardioband	Device; may not have full FDA approval
Carillon Mitral Contour System	Device; may not have full FDA approval
Harpoon	Device; may not have full FDA approval
Intrepid	Medtronic; may not have full FDA approval
NeoChord	Device; may not have full FDA approval
Tiara	Neovasc; may not have full FDA approval
TricValve	Device; may not have full FDA approval
TriGUARD 3	Keystone Heart; may not have full FDA approval